U.S. Pat, No. 4,728,637 (Silverman) discloses a pharmaceutical protein complex which includes fibronectin for treating humans and animals with degenerative diseases. The complex disclosed in U.S. Pat. No. 4,728,637 or alternatively, a pure fibronectin composition, is used in the method of the invention herein to treat cancer resections.
The aforementioned fibronectin complex which may be used in the inventive process herein comprises macromolecules produced from human and animal cultured cells, i.e. mesenchymal cells. The mesenchymal cell macromolecular complex used in this invention consists of fibronectin, with or without the macromolecules selected from procollagen, proteoglycan, elastin, laminin and mixtures thereof. As discussed in U.S. Pat. No. 4,728,637, fibronectin and procollagen are part of the compositions of that patent. Whether or not proteoglycan, laminin or elastin are present in the patent composition depends on the particular mesenchymal cell culture used to prepare the complex of the patent.
For purposes of simplification, the above composition of U.S. Pat. No. 4,728,637 is referred to as PROFIPEL.TM.. It is to be understood that this covers those instances where the composition contains all five ingredients--fibronectins, procollagens, proteoglycans, laminins and elastins; four ingredients--fibronectins, procollagens, proteoglycans, and either elastins or laminins; three ingredients--fibronectins, procollagens and proteoglycans, or the two ingredients, fibronectins and procollagens.
The macromolecules extracted from cultured mesenchymal cells, the PROFIPEL.TM., function with each other in consort and not individually. Therefore, they must not be considered as individual ingredients but must be considered as a complex of mesenchymal macromolecules.
The type of mesenchyrnal cells used to produce PROFIPEL.TM. can vary. Although it is not required, it is believed that for the treatment of a specific cancer resection, it would be best to prepare PROFIPEL.TM. from that type of mesenchymal tissue which is beneath the resection. For example, if the cancerous tissue is lung tissue, then the PROFIPEL.TM. used to treat the cancer resection is preferably collected from cultured lung mesenchymal cells, although any suitable cells may be used to prepare a pharmaceutically acceptable form of fibronectin. Thus, the source of fibronectin may be homologous, heterologous or autologous.
Postoperative recurrence of cancer locally in the incision site is a major problem with the surgical treatment of cancer. Local recurrence predominantly occurs in the central scar and under the skin graft. For instance, chest wall recurrence after radical mastectomy for breast cancer occurs in 10 to 15% of the patients (Cancer 20:1051-1053, 1967; Cancer 57:1421-1425, 1986; J. Surg Oncol 30:149-151, 1985; Arch Surg 111:323-325, 1976). The prognostic significance of local recurrence is ominous, with 3.9% and 0% survival after 5 and 10 years, respectively (Cancer 20:1051-1053, 1967). Depending on the site and type of cancer, local recurrences occur in 5% to 60% of patients undergoing surgical treatment for other kinds of cancer. Research scientists have formulated the hypothesis that such recurrences are due to facilitated lodgement, and subsequent growth, of cancer cells from the patients' circulation at the surgical wound area (Cancer 20:23-30, 1967; J Surg Oncol 30:33-45, 1985; Ann Surg 168:887-890, 1968; Cancer Res 12:929-932, 1959; Cancer 28:545-552, 1971). Local recurrence may also result from inadequate removal of the cancer, i.e., due to leaving cancer cells in the operative site. Similar problems occur in veterinary medicine. In veterinary surgical treatment of animals for cancer, local recurrences may occur for the same reasons as in humans.